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Quality & Regulatory Compliance Specialist - (61118) - Libertyville, IL

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Job Title

Quality & Regulatory Compliance Specialist

Business Center

STERIS -> Government Affairs -> Isomedix MidWest Plant Operations-Government Affairs

Primary & Secondary Locations

Libertyville Office - Libertyville, IL 60048 US (Primary)

Job Description

Join STERIS in its vision to see the world free from
Infection and Contamination as a

Quality & Regulatory Compliance Specialist


Summary

The mission of the STERIS Quality & Regulatory Compliance function is to implement repeatable and sustainable processes to ensure on-going compliance with domestic and international regulations and standards. This includes evaluating the relevance to all STERIS facilities and products and implementing efficient and effective processes to ensure adherence to applicable regulations and standards.

This position will have the responsibility to support the Manager, Quality & Regulatory Compliance in the Libertyville North facility, supporting implementation of efficient and effective processes throughout all of Isomedix facilities.


Duties


1. Provide support to the Quality & Regulatory Compliance Manager in the development, enhancement, standardization, execution and implementation of notified body, software and equipment validation, and supplier quality standards/processes within STERIS Isomedix.

2. Support the Quality & Regulatory Compliance Manager in all validation activities, including, but not limited to: software assessment documentation, risk documentation, protocol planning, generation, and execution for off-the-shelf software, spreadsheet validation, equipment and process validation.

3. Support the Quality & Regulatory Compliance Manager in the notified body program through coordination of facility audit scheduling, invoice tracking, and issue resolution.

4. Support the Quality & Regulatory Compliance Manager through coordination of the supplier program, including: qualifications and/or audits, routine monitoring, assessment meetings, action requests, and CAPA process, as necessary ensure resolution of issues.

5. Provide support to the Quality and Regulatory Compliance Manager in the investigation and resolution of assigned global CAPAs.

6. Support FDA and other Regulatory Agency responses following receipt of formal observations, at the direction of the Director, Quality and Regulatory Compliance.

7. Collaborate with colleagues as requested, in support of the ongoing maintenance of Isomedix Regulatory and Quality System policies and procedures, including periodic reviews or updates following process changes; employee training; and implementation and/or monitoring of CAPA actions.

8. Support the on-going compliance reviews at Isomedix facilities, as needed, inclusive of daily run/load record review, observation of dosimeter reading and handling practices, etc.

9. Support continuous improvement efforts within the facility and the organization through participating in quality and performance improvement projects as requested.

10. Support a safe, clean and secure working environment by supporting procedures, rules and regulations; supports plant safety committees that evaluate plant machinery, equipment and working conditions.

11. Conduct yourself in accordance with the principles of the STERIS Code of Business Conduct and comply with all Company policies.

12. Protect company confidential information by properly storing, retrieving and disseminating such information only to those authorized.

The Quality & Regulatory Compliance Specialist will have exposure to the following regulations and standards:

• 21 CFR Part 820 – Medical Device Quality System Regulations (QSR)
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
• 21 CFR Section 1271.150 – Current Good Tissue Practice (cGTP)
• 21 CFR Part 11 – Electronic Records, Electronic Signatures
• ISO 13485: Medical devices – Quality management systems
• Health Canada, Food & Drug Regulations, Div. 2, Part C: Good Manufacturing Practices – Drugs
• EN ISO 11135-1:2007 – Sterilization of healthcare products – Ethylene Oxide
• EN ISO 11137-1:2006 – Sterilization of healthcare products – Radiation
• ISO/IEC 17025: General requirements for the competence of testing and calibration laboratories [Biotest Labs]

Job Requirements

Education

Bachelor’s Degree - Scientific, Engineering, Clinical or Regulatory fields of study

Professional Certification in Regulatory Compliance or Quality Systems preferred

Experience

Minimum of two years experience in quality engineering, validation or auditing environment preferred.

Experience working in regulated industry preferred.

Skills

1. Demonstrated ability to project and time manage and to problem-solve.

2. Self-starter that is highly organized

3. Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective actions; able to work effectively and professionally with external people including Customers and government officials.

4. Strong oral and written communication skills

5. Excellent PC skills, including Microsoft Office applications

6. Experience in working on cross-functional teams; able to lead cross-functional team when required.

7. Ability to balance multiple high priority responsibilities on-time and effectively.

8. Demonstrate through your daily activities a model of continuous monitoring of our quality system activities to ensure compliance to documented standards.

9. Ability to analyze data and performance measures

 

STERIS is a $1.5B+, publicly traded (NYSE) organization of over 6000 employees and is dedicated to providing innovative infection prevention, decontamination, and health science technologies, products and services.

STERIS Corporation complies with all obligations with respect to online application systems under guidelines provided by the US Department of Labor's Office of Federal Contract Compliance Programs. If you are a disabled person who requires reasonable accommodation to complete an online application, please contact the STERIS Human Resources Department by phone at 440-392-7047 or 800-548-4873, extension 27047 for assistance.

STERIS Corporation is an Equal Employment Opportunity (EEO) employer and welcomes all qualified applicants. Applicants will receive consideration without regard to race, sex, color, religion, national origin, age, disability, veteran status, genetic data, or religion or other legally protected status.

Career Level

Experienced (Non-Manager)

Education

Bachelor's Degree

Travel

Category

Quality

Shift Type

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